42 U.S.C. § 289g–5 — Precision medicine initiative

(a) The purpose. The Secretary is encouraged to start and run an initiative called the "Precision Medicine Initiative." Its goal is to add to existing efforts to prevent, diagnose, and treat disease. (b) What it can include. The Initiative may build a network of scientists to help carry it out. It may develop new approaches to scientific, medical, public health, and regulatory science problems. It may apply genomic technologies, such as sequencing a person's entire genome, to learn about the molecular causes of disease. It may collect information that a diverse group of people volunteer to share, to better understand health and disease. And it may include other activities the Secretary decides fit the Initiative's goals. (c) What the Secretary may do. In running the Initiative, the Secretary may work with the Secretary of Energy, private companies, and others to identify and meet the Initiative's need for advanced supercomputing and other technology. The Secretary may build and use public-private partnerships. And the Secretary may make use of data that already exists. (d) What the Secretary must do. The Secretary must make sure the National Institutes of Health, the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the Department's Office for Civil Rights all work together on the Initiative. The Secretary must follow existing laws and rules that protect people who take part in research, including protecting their privacy. The Secretary must put in place policies and tools for sharing data securely across systems, with protections for privacy and security built in. The Secretary must think about the diversity of the group of volunteers, including biological, social, and other factors that create health disparities, to make sure a broad range of people are included. The Secretary must make sure that only authorized people can access controlled or sensitive material and information that identifies a person, when that material is collected or stored for the Initiative. And on an appropriate Department of Health and Human Services website, the Secretary must list any entity with access to that information — explaining why it has access, summarizing the research project involved, and describing what material and information it can access. (e) Reporting. Within one year of December 13, 2016, the Secretary must send Congress a report on the Initiative's data access policies and procedures. The report goes to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. It must describe the steps the Secretary took to consult with outside experts or other agency heads while developing these policies.